MED-EL Opus 2 User Manual
  1. Manuals
  2. Brands
  3. MED-EL Manuals
  4. Hearing Aid
  5. OPUS 2
  6. User manual

MED-EL Opus 2 User Manual

Hide thumbs Also See for Opus 2:
Table of Contents

Advertisement

Quick Links

See also: Equipment Manual , Quick Manual
user manual

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the Opus 2 and is the answer not in the manual?

Questions and answers

Related Manuals for MED-EL Opus 2

Summary of Contents for MED-EL Opus 2

  • Page 1 user manual...
  • Page 2 MED-EL Worldwide Headquarters AW 5473 Rev. 1.0 (English US)

  • Page 3: Table Of Contents

    Additional wearing options Earhook/Microphone cover Safety lock Special considerations for young children General precautions and warnings General precautions for your Cochlear Implant System Precautions for medical procedures Care and maintenance Maintenance Batteries Weekly maintenance of your OPUS 2 speech processor...
  • Page 4 Table of contents Troubleshooting Speech Processor Test Device FineTuner OPUS 2 red indicator light Private alert FineTuner indicator functions 10. Technical data Speech processor FineTuner Speech Processor Test Device Symbols Guidance and manufacturer’s declaration 11. Appendices Warranty, guarantee and registration card...

  • Page 5: Introduction

    The adjustment to a cochlear implant and adequate fitting of the device are gradual processes that occur over time. It is important to remember that your ability to hear with your new MED-EL system may take a little time while you become accustomed to this new method of hearing.

  • Page 6: Intended Use - Indications - Contraindications

    Radiological evidence of cochlear ossification may justify a shorter trial with amplification. As the OPUS 2 is a component of the MED-EL Cochlear Implant System, all indications stated for the Cochlear Implant System are applicable.

  • Page 7: Contraindications

    Intended use – Indications – Contraindications CONTrAINdICATIONS A patient must not receive an OPUS 2 speech processor if the individual is known to be intolerant of the materials used in the OPUS 2 control unit, battery pack, earhook, FM Battery Pack Cover or FineTuner.

  • Page 8: Getting Started

    4. GETTING STArTEd ThE pArTS OF ThE SySTEm The MED-EL Cochlear Implant System is an active medical device that has internal (implanted) and external parts. The internal part of the device is surgically implanted behind the ear in the skull, while the external components are worn behind the ear or on the body.
  • Page 9 The external parts include the OPUS 2 speech processor and the speech processor accessories. In its basic configuration, the OPUS 2 speech processor consists of the control unit with the earhook attached, the battery pack frame and cover, the connecting piece, the coil and the coil cable.

  • Page 10: Opus 2 Speech Processor

    Fig. 4 The OPUS 2 speech processor in position ON After switching on the OPUS 2 speech processor, the red indicator light in the earhook will blink up to four times indicating the activated program (i.e. number of blink signals corresponds to the number of activated program).

  • Page 11: Finetuner

    FineTuner. The typical maximum operating distance between the FineTuner and the OPUS 2 speech processor is approximately 80 cm (2.62 ft.). This range could be decreased close to electronic and electrical equipment even if this equipment complies with all applicable electromagnetic emission requirements.
  • Page 12  . These buttons are also required in programming mode, e.g. to activate or deactivate the keyboard lock (see Chapter 5, OPUS 2 speech processor, FineTuner, FineTuner functions - Automatic keyboard lock). All FineTuner controls can be selectively disabled by your audiologist or clinical staff by disabling the respective command in the control unit.
  • Page 13 OPUS 2 speech processor FineTuner functions automatic keyboard lock: To avoid unintentional operation of a key, the FineTuner features an optional automatic keyboard lock. This function electronically locks the keyboard if no key is pressed for more than 10 seconds.

  • Page 14: Battery Pack

    OPUS 2 speech processor BATTEry pACk The OPUS 2 battery pack consists of the battery pack frame holding 3 hearing aid batteries, and the battery pack cover. The battery pack cover slides over the battery pack frame and is held in place by the battery pack lock which also functions as the ON/OFF switch of the control unit (see Fig.
  • Page 15 For more wearing options see Chapter 5, OPUS 2 speech processor, Additional wearing options. An ear-mold may help keep the processor in position on the ear. Contact your CI center or...

  • Page 16: Coil

    OPUS 2 speech processor COIL The coil connects the OPUS 2 speech processor with the implant. It sends both energy and the coded acoustic signal through the skin to the implant. A small magnet is located in the center of the coil to hold it in place on the head over the implant package.
  • Page 17 OPUS 2 speech processor how to replace the coil cable Control unit 3 short pins Coil cable 1 long pin Fig. 7 Connecting the coil cable Open the battery pack lock and remove the battery pack cover. Pull the connecting piece straight down until you feel a slight mechanical click.The connecting piece need not be removed completely but you may do so if you wish.

  • Page 18: Connecting Assistive Listening Devices

    (FM Battery Pack Cover and Adapter Cable) are included in the Fm extension Kit which may be purchased separately. A special battery pack cover is provided to connect your OPUS 2 speech processor to external, battery-powered audio devices, such as portable CD players, MP3 players, AM-FM radios, etc.
  • Page 19 Mix cables are indicated by a yellow 3.5 mm plug. Ext mode: When connected to an external device, the OPUS 2 microphone is deactivated. You will hear input from the external device only. Ext cables are indicated by a red 3.5 mm plug.

  • Page 20: Additional Wearing Options

    OPUS 2 speech processor AddITIONAL WEArING OpTIONS BabyBTe /activeWear MED-EL’s signature wearing option for infants and young children is the BabyBTE . The BabyBTE has the advantage of allowing a young child to begin using the same ear-level speech processor that he or she will use for the long term, while still accommodating a baby’s small ear and activity level.
  • Page 21 For young children, it is mandatory to use the safety lock to prevent them from disassembling the speech processor (see Chapter 5, OPUS 2 speech processor, Safety lock). To insert batteries, open the battery pack lid of the Straight Battery Pack by pushing the lever at the back of the device as shown in Fig.
  • Page 22 OPUS 2 speech processor Children’s Battery Pack The control unit is worn at the ear, which provides optimal microphone placement and easy visibility of the red indicator light in the earhook. A cable allows the battery pack to be attached directly to clothing.
  • Page 23 For young children,it is mandatory to use the safety lock to prevent them from disassembling the speech processor (see Chapter 5, OPUS 2 speech processor, Safety lock). To insert batteries open the battery pack lid of the Children’s Battery Pack by pushing the lever at the back of the device as shown in Fig.

  • Page 24: Earhook/Microphone Cover

    OPUS 2 speech processor EArhOOk/mICrOphONE COvEr how to remove the earhook pin Your OPUS 2 speech processor is shipped with a pin securing the earhook to the control unit. This configuration is recommended when the user is a young child.

  • Page 25: Safety Lock

    Fig. 15 Safety lock 6. SpECIAL CONSIdErATIONS FOr yOuNG ChILdrEN The OPUS 2 speech processor has several features that are particularly designed for young children. Among them: • locked earhook: The earhook is secured to the control unit with a small pin.

  • Page 26: General Precautions And Warnings

    Do not use the MED-EL Cochlear Implant System with any device other than those listed in this manual or approved by MED-EL. If you have problems with any component of the system, refer to Chapter 9, Troubleshooting.

  • Page 27: General Precautions For Your Cochlear Implant System

    GENErAL prECAuTIONS FOr yOur COChLEAr ImpLANT SySTEm The OPUS 2 speech processor and other parts of the system contain sophisticated electronic components, which need special precautions regarding electromagnetic compatibility (EMC). When activating your OPUS 2 speech processor always follow the guidelines outlined in this section and Chapter 10, Technical data, Guidance and manufacturer’s declaration.
  • Page 28 The defined operating temperature range is between +10°C and +45°C (+50°F and +113°F) for the OPUS 2 speech processor and the FineTuner. Normally, when the OPUS 2 speech processor is worn on the body, natural body heat helps maintain this temperature range.
  • Page 29 FineTuner will not be able to communicate with your processor until the processor is switched back on. In rare cases, a cochlear implant may trigger a security system alarm, so make sure that you always carry your MED-EL ID card with you in order to identify yourself as a cochlear implant user.
  • Page 30 Do not allow another person to touch the external parts of your implant system unless both you and the other person are “discharged”. • You should always discharge before taking off or putting on the OPUS 2 speech processor. To do this, use this two step approach: (A) When removing another person’s speech processor: Step 1 Touch the person’s body...
  • Page 31 Other physical activity is generally allowed. Make sure that you wear the OPUS 2 securely (see Chapter 5, OPUS 2 speech processor, Additional wearing options) to protect it from physical damage. Sports that require a helmet are okay as long as they do not exceed the given capabilities of the user.

  • Page 32: Precautions For Medical Procedures

    Switch off and remove your OPUS 2 speech processor in the vicinity of strong ionizing radiation like X-ray diagnosis machines to prevent any possible interference with the electronics.
  • Page 33 CI surgery can be reduced by the meningitis vaccine, by using antibiotics before and after CI surgery and by using the surgical technique recommended by MED-EL. As with all cochlear implant surgery, preventative antibiotic usage is recommended for all patients unless medically contraindicated.

  • Page 34: Care And Maintenance

    Protect your OPUS 2 speech processor from water (see also Chapter 7, General precautions and warnings). Do not try to repair electronic parts of your OPUS 2 speech processor and do not try to open the control unit. Do not touch the battery contacts. If the contacts need to be cleaned, use a cotton swab and a small amount of cleaning alcohol.

  • Page 35: Batteries

    Care and maintenance BATTErIES In its current version, the OPUS 2 speech processor requires three 675 zinc air batteries. These batteries supply the external and internal components with energy. If you want to get more information on batteries, please contact your local MED-EL representative or CI center.
  • Page 36 (see also Chapter 9, Troubleshooting). To change the batteries, proceed as follows Remove the coil from your head and switch off the OPUS 2 speech processor before replacing the batteries. Open the battery pack lock (a) and remove the battery pack cover (b).
  • Page 37 Care and maintenance Changing the battery of your FineTuner When your FineTuner generates an optical battery low warning signal (see also Chapter 5, OPUS 2 speech processor, FineTuner, FineTuner functions), it is recommended to replace the battery of your FineTuner.
  • Page 38 When changing the batteries for the BabyBTE /ActiveWear and Children’s Battery Pack options, proceed as described for the OPUS 2 speech processor. The only difference will be how to remove and attach the battery pack cover: To open the battery pack, push the lever at the back of the BabyBTE /ActiveWear and hold it in this position (a).

  • Page 39: Weekly Maintenance Of Your Opus 2 Speech Processor

    Care and maintenance WEEkLy mAINTENANCE OF yOur OpuS 2 SpEECh prOCESSOr Thoroughly wipe the external parts of your OPUS 2 speech processor with a tissue and let them dry completely. Drying your OPus 2 speech processor The speech processor system includes a drying kit (drying box) and 4 drying capsules.

  • Page 40: Troubleshooting

    Implant System or cause uncomfortable stimulation and the warranty may void. If you have any questions or problems, please get in touch with your CI center or nearest MED-EL office. Switching the speech processor on or off can cause a soft sound. You can remove the coil before operating the switch if this bothers you.

  • Page 41: Finetuner

    OPUS 2 and/or go to a different location. • The OPUS 2 and the FineTuner are not synchronized. In this case you need to refer to the section described in Chapter 5, OPUS 2 speech processor, FineTuner, How to configure your FineTuner.

  • Page 42: Opus 2 Red Indicator Light

    To enable this command you will need to contact your clinic, CI center or MED-EL. • The red indicator light in the OPUS 2 has been disabled by your audiologist during fitting.To enable the red indicator light you will need to contact your clinic, CI center or MED-EL.
  • Page 43 Troubleshooting Warning patterns Blinking pattern meaning action to take remarks Batteries empty Switch processor off. If the processor is approx. 1s Change the batteries. not switched off, Switch processor the red indicator back on. light will continue to blink. Maximum or Stop pushing minimum value of button(s) on...

  • Page 44: Private Alert

    FineTuner is pressed. Confirmation signal If a command from the FineTuner has been executed successfully by the OPUS 2 speech processor, a confirmation beep is audible for the user of the speech processor.

  • Page 45: Finetuner Indicator Functions

     is pressed for more than 5 seconds (must be unlocked; see Chapter 5, OPUS 2 speech processor, FineTuner, FineTuner functions for locking/unlocking instructions), the FineTuner enters the program mode. The three indicator lights start flashing. When the red indicator light is on, the two amber indicator lights are off and vice versa.

  • Page 46: Technical Data

    Technical data 10. TEChNICAL dATA SpEECh prOCESSOr dimensions of OpuS 2 speech processor (mm) 35.1 mm 7.0 mm (0.276 in.) (1.382 in.) 15.7 mm (0.618 in) 8.7 mm (0.343 in.) Weight 12.4 g (0.437 oz) (including batteries) typical values power supply 3 hearing aid batteries type 675 zinc air (1.4 V)
  • Page 47 Technical data Audio Input • Via FM Battery Pack Cover • Hearing aid type three pin connection (Euro-Audio) acc. to IEC 60118-12 • Sensitivity -61.4 dBV (corresponds to 70 dB SPL at 1 kHz) • Impedance 2.9 kΩ typical values Controls/Indicators •...

  • Page 48: Finetuner

    Technical data uNEr dimensions Length 85.5 mm (3.336 in.) Width 54 mm (2.126 in.) Height 6.3 mm (0.248 in.) Weight 33 g (1.164 oz) (incl. battery) typical values Controls / Indicators • Default key • Volume keys • Sensitivity keys •...

  • Page 49: Speech Processor Test Device

    (2) this device must accept any interference received, including interference that may cause undesired operation. Warning: Changes or modifications made to this equipment not expressly approved by MED-EL may void the FCC authorization to operate this equipment. nOTe: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.These limits are designed to provide reasonable protec-...

  • Page 50: Symbols

    Directive 90/385/EEC (Active Implantable Medical Devices/AIMD). CE mark applied in 2006 The OPUS 2 speech processor and the FineTuner (RF link) comprise “Class 2” radio equipment under the R&TTE directive. Hereby MED-EL declares that the OPUS 2 speech processor and the FineTuner...

  • Page 51: Guidance And Manufacturer's Declaration

    Electromagnetic emissions for all equipment and systems Guidance and manufacturer’s declaration – electromagnetic emissions The OPUS 2 is intended for use in the electromagnetic environment specified below. The customer or the user of the OPUS 2 should assure that it is used in such an environment.
  • Page 52 Electromagnetic immunity – for all equipment and systems Guidance and manufacturer’s declaration – electromagnetic immunity The OPUS 2 is intended for use in the electromagnetic environment specified below.The customer or the user of the OPUS 2 should assure that it is used in such an environment.
  • Page 53 If the measured field strength in the location in which the OPUS 2 is used exceeds the applicable RF compliance level above, the OPUS 2 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the OPUS 2.
  • Page 54 OPus 2 The OPUS 2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.The customer or the user of the OPUS 2 can help prevent electromagnetic interference (resulting in the perception of a “buzzing sound”) by maintaining a minimum distance between portable and mobile...

  • Page 55: Appendices

    Statutory warranty claims shall not be granted unless the registration card is completed and returned to MED-EL within 30 days of the initial fitting for newly purchased systems. The warranty period for the OPUS 2 speech processor system begins with the date of first speech processor fitting.
  • Page 56 Fax: +49-8151-77 03-23 New Delhi, 110019 India office @medel.de Tel.: +91-11-4160 7171 Fax: +91-11-4164 2800 implants@medel.in MED-EL Deutschland GmbH Büro Berlin Schloßstr. 57 14059 Berlin, Germany MED-EL China Office Tel.: +49-30-383779-50 2110 Unit, Tower A, SOHO New Town, Fax: +49-30-383779-55 NO.88, Jian Guo Road, Chao Yang District,...

Table of Contents